Clinical Medicine Reviews in Therapeutics

Golimumab is the fifth tumor necrosis factor (TNF) alpha inhibitor approved by the Food and Drug Administration for the treatment of rheumatoid arthritis. It is a fully humanized monoclonal antibody which exhibits high affinity for both transmembrane bound and soluble TNF. Based on data from the clinical trials, golimumab is only approved to be used in combination with methotrexate since golimumab monotherapy was not more efficacious than methotrexate monotherapy. Efficacy has been established in three patient populations: methotrexate naïve; methotrexate tolerant; and prior TNF alpha discontinuation. In all patient populations golimumab 50 mg subcutaneous injection every four weeks resulted in an improved patient response. The most common adverse effects are injection site reactions, nausea and liver enzyme increases. Golimumab also has two black box warnings for increased risk of infection and malignancy. Based on the limited indication and lack of long term data, golimumab should be reserved for patients who have failed other TNF alpha inhibitors.